Kathy O’Loughlin, executive director of the ADA, says there is very little scientific evidence that the tests being marketed to dental professionals are reliable.
The American Dental Association (ADA) is urging dentists to be cautious about using novel coronavirus diagnostic tests before they have been properly evaluated and made available for dental professionals.
“The testing market is becoming a bit of the Wild West for companies right now,” Kathy O’Loughlin, DDS, executive director of the ADA, told ADA News. “There is very little scientific evidence that the tests being marketed to dentists are reliable, so be careful when you see an offer that seems ‘too good to be true.’”
The ADA Science and Research Institute is reportedly evaluating the evidence regarding tests and the level of specificity and sensitivity and is talking directly to manufacturers and distributors.
O’Loughlin added that all dentists need a fast point-of-care test that accurately predicts the presence or absence of COVID-19 virus in real time, but such tests have failed to meet specificity or sensitivity standards.
On April 17, via a letter to the Department of Health and Human Services, Chad Gehani, DDS, president of the ADA, and O’Loughlin asked permission to use its discretionary authority during public health emergencies to extend targeted liability protections for dental professionals who administer those COVID-19 diagnostic tests, similar to the protections offered to pharmacists on April 8.
For now, the ADA strongly advises dental professionals to steer clear of so-called “gray market” point-of-care tests for COVID-19, recommending they follow the direction issued by the FDA regarding testing procedures in their practices. Industry practitioners should also be aware that manufacturers and distributors are prioritizing the distribution of the available kits to facilities with high-level needs.
According to O’Loughlin, there is one test, ID Covid Now, that is being sold through Henry Schein to the medical community, but not to dentists. It is a fast point-of-care test manufactured by Abbott Labs, and they are reported to be only able to produce 50,000 tests per day.
Because of the medical demand, Henry Schein told the ADA they are not going to sell this point-of-care test to dentists in the very near future.
The Association does not consider COVID-19 testing to be a scope of practice issue, in that dentists are expected to routinely screen for high blood pressure, smoking habits and in some offices blood sugar and A1c levels. The test is not diagnostic in a dental office, since dentists are not treating COVID-19 illness.
Licensed dentists are eligible to administer COVID-19 diagnostic tests within their scope of practice, provided they obtain (or already have) a Certificate of Waiver from the Centers for Medicare & Medicaid Services, as may be needed. Like physicians, dentists may need the certificate to administer FDA-waived COVID-19 diagnostic tests, as required by the Clinical Laboratory Improvement Amendments (CLIA) regulation. Currently, to obtain a CLIA waiver, dentists must submit an application and pay a $150 application fee. The ADA is lobbying Congress to waive the certificate requirement or at least waive the application fee.